NDA approval from NMPA CDE for Opamtistomig (LBL-024) to initiate Ph 3 trial for 1L EP-NEC
Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, stated: “The Phase Ib/II data for Opamtistomig in first-line treatment of EP-NEC are encouraging. In our communications with the CDE, we have seen the regulatory agency’s strong focus on unmet clinical needs and its recognition of Opamtistomig’s clinical value. Based on the clear regulatory feedback, we are rapidly implementing the pivotal Phase III study protocol, and we look forward to validating its potential to extend patient survival through a high-quality trial, bringing this innovative therapy to EP-NEC patients as soon as possible.”
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